A Randomized Trial of a Mobile Health Exercise Intervention for Older Adults With Myeloid Neoplasms

NCT ID: NCT04981821

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2026-12-31

Brief Summary

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This is a phase 2 randomized controlled trial (RCT) to assess the preliminary efficacy of the a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education control in 100 older patients with MN receiving outpatient chemotherapy on physical function and patient-reported outcomes (fatigue, mood, and quality of life). We will also explore the effect of the intervention on TNFα and related cytokine gene promoter methylation and their gene and protein expression.

Detailed Description

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Up to 98% of older patients with myeloid neoplasms experience physical function decline, fatigue, and mood disturbances. Mobile health exercise interventions are promising strategy to prevent physical function decline and improve fatigue and mood disturbances, but older patients with myeloid neoplasms receiving outpatient chemotherapy are understudied. The proposed study will investigate whether a novel mobile health exercise intervention that is adapted to this population can prevent physical function decline, improve fatigue and mood disturbances, and prevent worsening quality of life.

Conditions

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Cancer Myeloid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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GO-EXCAP

GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©®) is a progressive walking and resistance exercise program

Group Type EXPERIMENTAL

GO-EXCAP Mobile App

Intervention Type BEHAVIORAL

A mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©®) is a progressive walking and resistance exercise program

Behavioral Placebo Control

Participants will meet with an oncology nurse (for approximately 60 min) to review the NCI booklet Chemotherapy and You: Support for People With Cancer, which includes facts about chemotherapy and its side effects. They will be provided with NCI online resources to review at home.

Group Type ACTIVE_COMPARATOR

Behavioral Placebo Control

Intervention Type BEHAVIORAL

Participants will meet with an oncology nurse (for approximately 60 min) to review the NCI booklet Chemotherapy and You: Support for People With Cancer, which includes facts about chemotherapy and its side effects. They will be provided with NCI online resources to review at home.

Interventions

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GO-EXCAP Mobile App

A mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©®) is a progressive walking and resistance exercise program

Intervention Type BEHAVIORAL

Behavioral Placebo Control

Participants will meet with an oncology nurse (for approximately 60 min) to review the NCI booklet Chemotherapy and You: Support for People With Cancer, which includes facts about chemotherapy and its side effects. They will be provided with NCI online resources to review at home.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥60 years (conventional definition of older age in clinical trials of MN)
* Have a diagnosis of MN
* Planned for or receiving outpatient cancer-directed treatments (participants receiving consolidative or maintenance outpatient therapies after induction chemotherapy are allowed to enroll)
* English speaking
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
* No medical contraindications for exercise per oncologist
* Able to walk 4 meters as part of Short Physical Performance Battery measured walk (with or without assistive device)
* Able to provide informed consent

Exclusion Criteria

* Physical, psychological, or social impairments that would interfere with subject's ability to participate in the study or participate in the intervention, as determined by the PI or the treating team
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Kah Poh Loh

Assistant Professor - Department of Medicine , Hematology/Oncology (SMD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kah Poh Loh

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester Medical Center/Wilmot Cancer Institute

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kah Poh Loh

Role: CONTACT

585-275-5863

Becky Gravenstede

Role: CONTACT

585-727-4728

Facility Contacts

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Kah Poh Loh, MBBCh BAO, MS

Role: primary

References

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Loh KP, Sanapala C, Jensen-Battaglia M, Rana A, Sohn MB, Watson E, Gilmore N, Klepin HD, Mendler JH, Liesveld J, Huselton E, LoCastro M, Susiarjo M, Netherby-Winslow C, Williams AM, Mustian K, Vertino P, Janelsins MC. Exercise and epigenetic ages in older adults with myeloid malignancies. Eur J Med Res. 2023 May 30;28(1):180. doi: 10.1186/s40001-023-01145-z.

Reference Type DERIVED
PMID: 37254221 (View on PubMed)

Other Identifiers

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R00CA237744

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCCS21043

Identifier Type: -

Identifier Source: org_study_id

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